UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Title of the study (Brief title)	Usefulness of cancer rehabilitation of multidisciplinary cooperation in the hematological malignancy
Region	Japan

Condition
Condition	Malignancy
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study investigates the effects of physiotherapy and game equipment that focuses of physical function and psychological status in hematological malignancy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of activity,Knee extension strength,Grip strength,Timed Up and Go test,Functional Reach test,30 seconds chair stand test,Profile of Mood States Brief Form. Evaluation time is performed before intervention starting for more than 30 minutes in the physiotherapy starting date, 1 week later and 2 weeks later.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The control group estimates physical function and psychological status as the physiotherapy starting date,one week later,two week later. In addition, physical therapist(Aerobic exercise, muscle strength training and balance practice, 40 minutes every day) do physiotherapy for one week.After that,Physical therapy in combination the game equipment(Aerobic exercise, muscle strength training and balance practice, 40 minutes every day) do physiotherapy for one week.
Interventions/Control_2	The intervention group estimates physical function and psychological status as the physiotherapy starting date,one week later,two week later.In addition, Physical therapy in combination the game equipment do physiotherapy(Aerobic exercise, muscle strength training and balance practice, 20 minutes every day and Wii Fit U, 20 minutes every day) for one week.After that,physical therapist(Aerobic exercise, muscle strength training and balance practice, 40 minutes every day) do physiotherapy for one week.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The hematological malignancy who enforces physiotherapy
Key exclusion criteria	The person who require assistance to walk,The person who have complications to affect the gait remarkably,The person who has difficulty in self-entry of the question paper list,The person who has difficulty in instructions understanding by the language,The person that it is predicted that I cause a change and fatigue of remarkable vital signs at the time of an evaluation,The person whom a state is unstable from head to foot in
Target sample size	30

Research contact person
Name of lead principal investigator	daiyu kobayashi
Organization	Saitama Medical School synthesis medical center
Division name	Rehabilitation
Address	1981, Kamoda, Kawagoe-shi, Saitama
TEL	0492283529
Email	kobayashidaiyu@yahoo.co.jp

Public contact
Name of contact person	daiyu kobayashi
Organization	Saitama Medical School synthesis medical center
Division name	Rehabilitation
Address	1981, Kamoda, Kawagoe-shi, Saitama
TEL	0492283529
Homepage URL
Email	kobayashidaiyu@yahoo.co.jp

Sponsor
Institute	Saitama Medical School synthesis medical center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 23 Day
Anticipated trial start date	2016 Year 04 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 23 Day
Last modified on	2018 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024898